# US 10,870,695 B2 · Biopharmaceutical compositions comprising interleukin-5 antibody > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,870,695 B2 - Document ID: US10870695B2 - Status: Granted - Kind: B2 - Application number: 15/754,768 - Filed: 2016-08-22 - Published: 2018-09-06 - Granted: 2020-12-22 - Earliest claimed: 2015-08-24 - Assignees: GlaxoSmithKline Intellectual Property (No. 2) Limited - Applicants: Glaxosmithkline Intellectual Property (No. 2) Limited - Inventors: Myrna A. Monck; Narendra B. Bam; Jennifer Dally; Michelle Spatara - Web page: https://patentgrep.com/patent/US10870695B2 ## CPC - C07K 16/244: {Interleukins [IL]} - A61K 39/39591: {Stabilisation, fragmentation} - A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants - A61P 9/00: Drugs for disorders of the cardiovascular system - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) - A61P 11/02: Nasal agents, e.g. decongestants - A61P 11/06: Antiasthmatics - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/40: characterized by post-translational modification - C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin - C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present disclosure relates to compositions, for treating interleukin 5 (IL-5) mediated diseases, and related methods. ## Claims ### Claim 1 A composition comprising a mixture of antibodies, the composition comprising: (i) an antibody having a heavy chain amino acid sequence as shown in SEQ ID NO: 1 and a light chain amino acid sequence as shown in SEQ ID NO: 2; and, (ii) an antibody having a heavy chain amino acid sequence as shown in SEQ ID NO: 1 and a light chain amino acid sequence as shown in SEQ ID NO: 2, except that residue 31 of SEQ ID NO: 2 is replaced with either an aspartic acid or an iso-aspartic acid. ### Claim 2 (depends on 1) The composition according to claim 1, wherein the antibody of (ii) comprises from 3.3% to 25% of the composition. ### Claim 3 (depends on 2) A composition according to claim 2 wherein the composition has at least 0.70 IL-5 specific antigen binding activity compared with a reference standard composition, the reference standard composition comprising: (a) an antibody having a heavy chain amino acid sequence as shown in SEQ ID NO: 1 and a light chain amino acid sequence as shown in SEQ ID NO: 2; (b) ≥98% HC C-terminal lysine deleted variant of the antibody of (a); (c) ≥95% HC N-terminal pyroglutamate variant of the antibody of (a); (d) 5.2% of the antibody of (a) wherein residue 31 of SEQ ID NO: 2 is replaced with either an aspartic acid or an iso-aspartic acid; (e) 0.9% of the antibody of (a) wherein residue M64 of SEQ ID NO: 1 is oxidized; (f) 0.1% of the antibody of (a) wherein residue W52 of SEQ ID NO: 1 is oxidized; and, (g) 0.4% aggregated antibodies of the reference standard composition. ### Claim 4 (depends on 2) A pharmaceutical composition comprising a composition according to claim 2 and a pharmaceutically acceptable carrier. ### Claim 5 (depends on 2) A composition according to claim 2 wherein the antibody is at a concentration of between 75 mg/mL to 100 mg/mL. ### Claim 6 (depends on 2) The composition of claim 2, wherein the composition further comprises: (a) ≥92% amino terminal pyroglutamate residue at amino acid residue 1 of the antibodies of the mixture of antibodies; (b) ≥90% carboxy terminal glycine amino acid residue at amino acid residue 448 of the antibodies of the mixture of antibodies; (c) from 1.5% to 6% of residue 386 of SEQ ID NO: 1 is replaced with either an aspartic acid or an iso-aspartic acid; (d) from 0% to 1% of residue W52 of SEQ ID NO: 1 is oxidized; (e) from 0.5% to 1.5% of residue M64 of SEQ ID NO: 1 is oxidized; (f) from 2.5% to 4.5% of residue M254 of SEQ ID NO: 1 is oxidized; (g) from 0.4% to 0.8% of residue M430 of SEQ ID NO: 1 is oxidized; and, (h) from 3.3% to 6.6% of residue 31 of SEQ ID NO: 2 is replaced with either an aspartic acid or an iso-aspartic acid. ### Claim 7 (depends on 2) The composition according to claim 2, where in the antibody of (ii) comprises from 3.3% to 6.6% of the composition. ### Claim 8 (depends on 2) The composition of claim 2, wherein greater than 50% of the heavy chain C-terminal lysine residue K449 is deleted. ### Claim 9 (depends on 2) The composition according to claim 2, wherein the composition comprises from 0.5% to 55% of residue M64 of SEQ ID NO: 1 is oxidized and from 0% to 3% of residue W52 of SEQ ID NO: 1 is oxidized. ### Claim 10 (depends on 2) The composition according to claim 2, wherein the composition comprises from 0.5% to 55% of residue M64 of SEQ ID NO:1 is oxidized, from 2.5% to 55% of residue M254 of SEQ ID NO:1 is oxidized, from 0.4% to 55% of residue M360 of SEQ ID NO:1 is oxidized, from 0.4% to 55% of residue M430 of SEQ ID NO:1 is oxidized, and 0% to 3% of wherein residue W52 of SEQ ID NO:1 is oxidized. ### Claim 11 (depends on 2) The composition according to claim 2, wherein the composition comprises from 1.5% to 35% antibodies with residue 386 of SEQ ID NO: 1 replaced with either an aspartic acid or an iso-aspartic acid. ### Claim 12 (depends on 2) The composition according to claim 2, wherein the composition further comprises from 0.4% to 20% aggregated antibodies of the composition.